Research ArticleThe Effect of C-Arm Mobility and Field of Vision onRadiation Exposure in the Treatment of Proximal FemoralFractures: A Randomized Clinical Trial

Mahmut Kalem,1 Kerem BaGarJr,1 Hakan KocaoLlu ,1 Ercan Fahin ,2 and Hakan KJnJk1

1Department of Orthopedics and Traumatology, Ankara University Faculty of Medicine, Ankara, Turkey2Department of Orthopedics and Traumatology, Bulent Ecevit University Faculty of Medicine, Zonguldak, Turkey

Correspondence should be addressed to Hakan Kocaoglu; kocaoglu@ankara.edu.tr

Received 19 July 2017; Accepted 25 February 2018; Published 27 March 2018

Academic Editor: Amal Khoury

Copyright © 2018 Mahmut Kalem et al.This is an open access article distributed under the Creative Commons Attribution License,which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Objectives. To examine the effect of fluoroscopy devices with different sizes of image intensifier and C-arm maneuverabilityon operating time, fluoroscopy time, radiation dose and reduction, and fixation quality at intertrochanteric femoral fractures.Design. Single-center, randomized, prospective study. Setting. Academic Level I trauma hospital. Patients and Intervention. 34patients treated with cephalomedullary nailing for a stable, intertrochanteric proximal femur fracture (OTA A1). Main OutcomeMeasurement. The total working time of the fluoroscopy device, the dose-area product (DAP), operating time, reduction quality(cortical continuity, symmetrical collodiaphyseal angle, and shortness), and fixation quality (Bosworth quadrants, the tip-apexdistance, TAD). Results. There were no cases of poor reduction; also the placement of the blade was optimal for 14 patientsand suboptimal in 3 patients in each group. Superior-posterior placement of the blade or TAD > 25mm was not seen in anypatient. Total operating time was significantly shorter when using device A compared to the use of device B (20.1 ± 3.4minsversus 25.3 ± 5.4mins, 𝑝 < 0.001). Total radiation time was significantly shorter with device A compared to the use of device B(58.1 ± 19.4 secs versus 98.9 ± 55.4 secs, 𝑝 = 0.008). The measured radiation dose was lower with the use of device A compared todevice B (3.5 ± 1.2Gy⋅cm2 versus 7.3 ± 4.5Gy⋅cm2, 𝑝 = 0.002). Conclusion. Physical properties of fluoroscopy devices used duringthe fixation of intertrochanteric fractures could yield significant differences in operating times and the radiation dose while havingcomparable clinical results.

1. Introduction

The use of fluoroscopy for guidance in orthopedic traumasurgery has significantly increased, allowing for smaller sur-gical exposures to achieve reductions and internal fixation offractures [1–4]. Over the years, there has been a tremendousincrease in the use of fluoroscopy in orthopedic surgery,especially in treating proximal femur fractures [5, 6].

According to the aim for which current fluoroscopydevices are used, there are differences in software, power,working distance, maneuver capability of the C-arm, andimage intensifier size. The basic principle in reducing radi-ation exposure caused by fluoroscopy devices is to keep theionized radiation dose as low as possible [7, 8]. In literature ithas been reported that many parameters are known to affect

operating time, fluoroscopy time, and the consequent ionizedradiation dose. It is thought that one of these could be thetechnical property of the fluoroscopy device. Although theeffects of fluoroscopy devices with different properties onoperating time and radiation exposure have been researchedin orthopedic surgery, the effects on the outcomes of theiruse in proximal femur fracture percutaneous treatment arenot known [1, 9–12]. This study was undertaken with thethought that highC-armmaneuver capability and awide fieldof vision could have an effect on operating time and exposureto ionized radiation. Therefore, the aim of the study was toexamine the effect on operating time, fluoroscopy time, radia-tion dose, and reduction and fixation quality of 2 fluoroscopydevices of the same make and with the same software butwith different sizes of image intensifier, which affects the field

HindawiBioMed Research InternationalVolume 2018, Article ID 6768272, 6 pageshttps://doi.org/10.1155/2018/6768272

2 BioMed Research International

12 inches

71 cm 9 inches

66 cm

(1A)

(2A)

(1B)

(2B)

Figure 1: The distinct features of two fluoroscopy devices used (device A, OEC 9900 Elite, General Electric Healthcare, USA; device B, OECBrivo 785 Essential, General Electric Healthcare, USA). ((1A) and (1B)) Device A having a bigger image intensifier size and longer C-arm depth,which affects the field of vision, when compared to device B. ((2A) and (2B)) Device A has more degree of freedom of C-armmaneuverabilitywhen compared to device B.This enables the technician to find the area of interest only moving the C-arm while keeping the device still thusfacilitating the use during surgery.

of vision, and different C-arm maneuver capability, whichfacilitates use during surgery; the devices were used by thesame surgeon in the treatment of stable intertrochantericfemoral fractures using single fixation device.

2. Patients and Method

This single-center, prospective study included 34 patientstreated with cephalomedullary nailing for a stable, inter-trochanteric proximal femur fracture (Orthopaedic TraumaAssociation [OTA] A1 classification). Approval for the studywas granted by the Local Ethics Committee. BetweenDecember 2016 and March 2017, a total of 134 consecutivepatients presented at the Emergency Department of a majortrauma center following a fall and were diagnosed withintertrochanteric femoral fracture and were treated withclosed reduction and fixation with cephalomedullary nailing.Demographic characteristics (age, gender, side, and bodymass index) were recorded as well as data related to thefracture type, operating time, the fluoroscopy device used,fluoroscopy time, radiation dose and reduction, and fixationquality. Patients with an AO/OTA Type A1 (stable) fractureand age > 60 years were included in the study. Patients withan additional fracture or pathological fracture were excludedfrom the study. Informed consent was obtained from all thepatients or from a first-degree relative in the case of patientswith dementia. All patients were operated on within 48 hoursof arrival at the hospital.

From the total 134 patients, 40 were A1 stableintertrochanteric fractures. Randomization was achieved bythe availability of the devices, when the patient was operatedon. 17 patients were operated on with device B (OEC Brivo785 Essential, General Electric Healthcare, USA) on dayswhen device A (OEC� 9900 Elite, General Electric Healthcare,USA), which has the property of being able to apply digitalsubtraction angiography (DSA), was used by the vascularsurgeons and 23 patients were operated on with device Ain the orthopedic operating theatre on days when it wasavailable. These two fluoroscopy devices were of the samemake and with the same software but with different sizesof image intensifier, which affects the field of vision, anddifferent C-arm maneuver capability, which facilitates useduring surgery (Figure 1). Patients operated on using deviceA were BMI matched to the 17 patients of device B and thusthe 2 study groups were formed (Figure 2).

All the patients were given regional anesthesia and wereoperated on in a supine position on a radiolucent table withthe fractured hip and whole extremity draped. The fluo-roscopy device was set up on the opposite side in a mannerto show the fracture region. Fracture reduction and protec-tion were provided with manual traction only by a singleassistant. Reduction evaluation and the fixation applicationwere made under fluoroscopy guidance. All the operationswere performed by a single surgeon (MK). In all patients,internal fixation was applied using cephalomedullary nailing(standard proximal femoral nail antirotation, PFNA; Synthes

BioMed Research International 3

intertrochanteric femur fracture(n = 134)

Type A1, stable(n = 40)

Type A2/3(n = 94)

Device A(n = 23)

Device B(n = 17)

BMI matched,34 patients,(17 = 17)

Figure 2: Scheme explaining patient selection process.

GmbH, Oberdorf, Switzerland). The fluoroscopy device inautomatic dose control mode was used by the same radiologytechnician in all cases.

The total working time of the fluoroscopy device duringthe surgical procedure and the radiation dose used wereobtained from the records of the fluoroscopy device at theend of surgery.Thedose-area product (DAP) recorded duringfluoroscopy imaging was the measurement method of theradiation dose selected in this study. DAP is a quantity used inassessing the radiation risk from radiographic examinationsand interventional procedures and is defined as the absorbeddosemultiplied by the area irradiated [6, 11, 13].The operatingtime was calculated as the time from the initial incision toclosure of the wound.

All the radiographic measurements were made by oneof the authors (ES, who is blinded to the surgical inter-vention) on the standard AP as well as lateral radiographsin internal rotation obtained at the end of surgery, usingCentricity PACS-IW software (General Electric Healthcare).Reduction quality was classified as described by Schipperet al. as anatomic (cortical continuity, symmetrical collodia-physeal angle, and no shortness), good (5∘–10∘ varus/valgus),and poor (>10∘ varus/valgus) [14]. For fixation quality, theCleveland-Bosworth quadrants were used which evaluate theposition of the neck screw within the femoral head andthe tip-apex distance (TAD) was measured [15]. Optimalfixation was accepted as central-central and inferior-centralplacement of the blade and TAD < 25mm. Placementsoutside of this were accepted as suboptimal fixation, with theworst being a superior-posterior placement.

Statistical evaluations were made using IBM SPSS 15(SPSS Inc., Chicago, IL, USA) software. Conformity of thedata to normal distribution was evaluated with the Shapiro-Wilk test. Numerical variables were stated as mean ± stan-dard deviation (SD) and categorical variables as percentages(%). Differences between the groups for numerical vari-ables not with normal distribution were examined with theMann–Whitney 𝑈 test. A value of 𝑝 < 0.05 was accepted asstatistically significant.

3. Results

The study included a total of 34 patients comprising 17 malesand 17 females with a mean age of 77.8 ± 9.0 years in thedevice A group and 77.8 ± 12.4 years in the device B group(𝑝 > 0.05) (Table 1).

When the radiological results were evaluated, in thedevice B group, anatomic reduction was obtained in 15patients (88.2%) and good reduction in 2 (11.8%). In thedevice A group, anatomic reduction was obtained in all 17patients (100%). There were no cases of poor reduction ineither group (𝑝 > 0.05) (Table 2).

When the fixation quality was evaluated, optimal place-ment of the blade was the same in both groups (𝑛 = 14,82.3%). Suboptimal placement was observed in 3 patientsin each group. Superior-posterior placement of the bladewas not seen in any patient. In both groups, the TADmeasurement was <25mm in all patients (Table 2).

Total operating time was significantly shorter when usingdevice A compared to the use of device B (20.1 ± 3.4mins

4 BioMed Research International

Table 1: The demographic distribution of patients.

Variable Device A (𝑁 = 17) Device B (𝑁 = 17)Age (yr) 77,8 ± 9,0 77,8 ± 12,4Gender

Female 10 (58,8%) 7 (41,2%)Male 7 (41,2%) 10 (58,8%)

LateralityLeft 9 (52,9%) 7 (41,2%)Right 8 (47,1%) 10 (58,8%)

Table 2: The demographic radiological results of patient.

Device A (𝑁 = 17) Device B (𝑁 = 17)Reduction

Anatomic 17 (100%) 15 (88,2%)Good - 2 (11,8)Bad - -

Blade positionOptimal 14 (82,3%) 14 (82,3%)Suboptimal 3 (17,7%) 3 (17,7%)

TAD (mm) 19,4 ± 2,9 22,0 ± 3,8

versus 25.3 ± 5.4mins, 𝑝 < 0.001). Total radiation timewas significantly shorter with device A compared to the useof device B (58.1 ± 19.4 secs versus 98.9 ± 55.4 secs, 𝑝 =0.008). The measured radiation dose was lower with the useof device A compared to device B (3.5 ± 1.2Gy⋅cm2 versus7.3 ± 4.5Gy⋅cm2, 𝑝 = 0.002) (Figure 3).

4. Discussion

The functional results following treatment of hip fractureswith percutaneous methods are closely related to reduc-tion and fixation quality and the most important factor inachieving this is obtaining a good quality field of visionduring the surgical procedure [10]. However, Mastrangeloet al. stated the importance of exposure to radiation causedduring imaging and reported that orthopedic surgeons wereexposed to 4 times more radiation than other surgeons and 8times more than other healthcare personnel and there wereincreased rates of cancer in those working in orthopedics[16]. The amount of ionized radiation that occurs duringimaging is known to be associated with the exposure time,the distance of the fluoroscopy device from the patient, theBMI of the patient, the projection angle and the extremitylevel, the type of operating table, and the experience ofthe surgeon [5, 12, 13, 17]. The results of the current studyrevealed that the technical properties of the fluoroscopydevice had a significant effect on operating time, fluoroscopytime, and the amount of ionized radiation. To discountvariables other than the fluoroscopy device in this study, allthe surgical procedures were performed by the same surgeon;the same fixation system was used with the considerationthat there may have been an effect of differences created

in the application of different systems, and only AO/OTAA1 fractures were examined which could be reduced withmanual traction only taking into consideration the effects thatcould have arisen from direct reduction methods.

The operating time for the treatment of intertrochantericfemoral fractures with closed reduction and nailing has beenreported in literature at varying periods in the range of20mins to 67mins [18–21].The reasons for such differences inthe measurement of operating time can be considered to bethat studies have been made on different types of fractures;the period has included different surgical steps, the type ofanesthesia, the use of manual traction or a traction table,the implant selection, and the experience of the surgeon.When the operating times of the current study are comparedwith those in literature, they are consistent and a significantdifference was determined between the groups (device A:20.1 ± 3.4min; device B: 25.3 ± 5.4min, 𝑝 < 0.001).

The fluoroscopy time in the closed reduction and nailingof intertrochanteric fractures has been associatedwith factorssuch as the severity of the fracture, implant selection, patientposition, and the experience of the surgeon and radiologytechnician [5, 22–25]. There has been mention in literatureof fluoroscopy times in trochanteric fractures with PFNAfixation but there are insufficient data on the use in stableA1 fractures. In a study by Zehir et al., the application ofPFNA was evaluated in 92 patients, most of whom had anA2 fracture, and fluoroscopy time was reported as a meanof 1.50min [26]. The fluoroscopy times in the current studywere consistent with those in literature and a statisticallysignificant difference was determined between the groups(device A: 58.1 ± 19.4 secs; device B: 98.9 ± 55.4 secs, 𝑝 =0.008).

When the radiation doses in the treatment ofintertrochanteric fractures with cephalomedullary nailingare evaluated in literature, the DAPmeasurements associatedwith the fluoroscopy times are between 0.8 and 11 Gy⋅cm2[27–29].Thedifferences in radiation dose are likely associatedwith surgical experience and competence and condition ofsurgical sites [27]. The DAP measurements in the currentstudy are consistent with literature and a statisticallysignificant difference was determined between the groups(device A: 3.5 ± 1.2Gy⋅cm2; device B: 7.3 ± 4.5Gy⋅cm2,𝑝 = 0.002).

To acquire images in a different plane, changing the placeof the fluoroscopy device takes a certain time and extraexposures during the procedure [2, 10]. Even there are twodistinct papers in the literature that argue the use of two C-arms simultaneously to face these problems [10, 30]. In thecurrent study, the significant difference between the groupsin respect of the operating times is thought to be due tothe difference in the C-arm maneuver capability. Due tothe larger image intensifier it was possible to take anterior-posterior and lateral images of the fracture region of interestin a single shoot and this was considered to be a reason forthe significant differences in fluoroscopy times and thereforethe doses of radiation exposure.

The most important limitation of the study was that thepower analysis results were not sufficient as the number of

BioMed Research International 5

A B

29

1

0

10

20

30

40

Tota

l ope

ratin

g tim

e (m

in)

(a)A B

8

1

0

50

100

150

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Tota

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8

,0

5,0

10,0

15,0

20,0

Tota

l rad

iatio

n do

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y·cm

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Figure 3: Box-plot graphs showing the results. (a) Box-plot showing total operation time for device A and device B. (b) Box-plot showingtotal radiation time for device A and device B. (c) Box-plot showing total radiation dose for device A and device B.

patients was low. Future studies examining more extensiveseries would be beneficial in establishing which parametersdirectly affect operating time, fluoroscopy time, and theamount of ionized radiation.

5. Conclusion

The results of this study showed that different physicalproperties of fluoroscopy devices used during the fixationof intertrochanteric fractures with cephalomedullary nailingcaused differences in operating times and the radiation dosewithout having any effect on the radiological results. It can beconsidered appropriate tomake the selection of a fluoroscopydevice taking into account the frequency of application andcost.

Disclosure

Level of evidence is therapeutic, Level I.

Conflicts of Interest

Mahmut Kalem, Kerem Basarır, Hakan Kocaoglu, and ErcanSahin declare that they have no conflicts of interest. HakanKınık has received a speaker honorarium from Smith &Nephew Plc.

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